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Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees
Sponsor: Saglik Bilimleri Universitesi
Summary
This prospective, observational cohort study evaluates the long-term outcomes of Regenerative Peripheral Nerve Interface (RPNI) surgery in patients with major lower extremity amputations suffering from symptomatic neuromas. RPNI is a surgical technique where the transected nerve end is implanted into a free autologous muscle graft to serve as a physiological target for reinnervation. The study aims to objectively assess the reduction in mechanical hypersensitivity using Pressure Pain Threshold (PPT) measurements via a digital algometer. Additionally, it monitors subjective neuropathic pain levels, functional mobility, and prosthesis satisfaction over a 24-month follow-up period compared to pre-operative baselines.
Official title: The Effect of Regenerative Peripheral Nerve Interface (RPNI) Surgery on Neuropathic Pain and Functional Outcomes in Major Lower Extremity Amputations
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2026-01-20
Completion Date
2030-03
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
Regenerative Peripheral Nerve Interface (RPNI) Surgery
The surgical procedure is standardized as follows to preserve the residual limb (stump) anatomy: * Approach: An 8-10 cm incision is made on the lateral thigh. For transtibial (below-knee) amputees, the incision is placed approximately 15 cm proximal to the knee joint. For transfemoral (above-knee) amputees, it is placed 5-10 cm proximal to the distal end of the residual limb. * Nerve Dissection: The sciatic nerve is isolated, dissected, and transected at its most distal point. Subsequently, it is separated into the Common Peroneal and Tibial divisions. * Fascicular Separation: Based on nerve thickness, intraneural dissection is performed to split the Common Peroneal nerve into 1 or 2 fascicles, and the Tibial nerve into 2 to 4 fascicles. * Graft Harvesting: Autologous muscle grafts are harvested to wrap these created fascicles. The donor site is standardized by amputation level: Vastus Lateralis muscle for transtibial amputees and Biceps Femoris muscle for transfemoral amputees.
Locations (1)
University of Health Sciences, Gulhane Training and Research Hospital, Department of Orthopedics and Traumatology
Ankara, Ankara, Turkey (Türkiye)